Trial · NCT01717742

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

NCT01717742, Phase 3, Completed, The Hospital for Sick Children; results first posted 2020-04-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial). Trials, record NCT01717742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01717742

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
NCT number: NCT01717742
Status: Completed
Phases: Phase 3
Enrollment: 97 participants, actual
Lead sponsor: The Hospital for Sick Children
Conditions: Pleural Empyema
Interventions: TPA (Tissue Plasminogen Activator), DNase, Placebo
First posted: 2012-10-30
Last updated: 2020-04-14
Results first posted: 2020-04-03

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Hospital Discharge	up to 4 months	Time from insertion of the chest drain to discharge from hospital.
Secondary	Time to Meeting Discharge Criteria	up to 4 months	Time from insertion of the chest drain to meeting discharge criteria. Discharge criteria: * Chest tube removed * No fever \[temperature less than 38°C\] * Normal respiratory rate forage * No hypoxia * Drinking fluids wel
Secondary	Time to Drain Removal	up to 4 months	Time from drain insertion to drain removal.
Secondary	Duration of Fever After Intervention	up to 4 months	Duration of fever (defined as temperature \>38 degrees celsius taken by any method) from insertion of the chest drain until resolution.
Secondary	Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention	up to 4 months	Number of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention.
Secondary	Number of Participants With Serious Bleeding	up to 4 months	Number of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion.
Secondary	Number of Participants With Further Interventions	up to 4 months	Number of participants who needed further intervention such as placement of another chest drain (by any technique) or surgical intervention such as thoracotomy and decortication, video-assisted thorascopic surgery, or pneumonectomy.
Secondary	Number of Participants With Hospital Readmission	3 months post-discharge	Number of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment.
Secondary	Cost of the Hospitalization	up to 4 months	An economic evaluation will compare the relative costs of DNase-tPA with tPA alone in previously well children who present with pleural empyema, using patient-level data from the trial.
Secondary	Mortality	up to 4 months	Mortality from any cause during the hospitalization for empyema.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Time to Hospital Discharge	up to 4 months	days	MEAN
SECONDARY	Time to Meeting Discharge Criteria	up to 4 months	days	MEAN
SECONDARY	Time to Drain Removal	up to 4 months	days	MEAN
SECONDARY	Duration of Fever After Intervention	up to 4 months	days	MEAN
SECONDARY	Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention	up to 4 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Serious Bleeding	up to 4 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Further Interventions	up to 4 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Hospital Readmission	3 months post-discharge	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cost of the Hospitalization	up to 4 months	2018 US $	MEAN
SECONDARY	Mortality	up to 4 months	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Hospital Discharge	Intervention	9.0	Standard Deviation 4.9	days
Time to Hospital Discharge	Control	9.1	Standard Deviation 5.3	days
Time to Meeting Discharge Criteria	Intervention	8.2	Standard Deviation 4.5	days
Time to Meeting Discharge Criteria	Control	8.5	Standard Deviation 5.4	days
Time to Drain Removal	Intervention	6.9	Standard Deviation 4.3	days
Time to Drain Removal	Control	6.9	Standard Deviation 5.3	days
Duration of Fever After Intervention	Intervention	2.8	Standard Deviation 3.4	days
Duration of Fever After Intervention	Control	3.3	Standard Deviation 3.4	days
Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention	Intervention	9		Participants
Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention	Control	8		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	tPA (Tissue Plasminogen Activator) and Placebo	48
Overall Study	STARTED	tPA (Tissue Plasminogen Activator) and DNase	49
Overall Study	COMPLETED	tPA (Tissue Plasminogen Activator) and Placebo	43
Overall Study	COMPLETED	tPA (Tissue Plasminogen Activator) and DNase	47
Overall Study	NOT COMPLETED	tPA (Tissue Plasminogen Activator) and Placebo	5
Overall Study	NOT COMPLETED	tPA (Tissue Plasminogen Activator) and DNase	2

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Intervention	0	49	0
other	Nausea	Gastrointestinal disorders	Control	2	48	2
other	Rash	Skin and subcutaneous tissue disorders	Intervention	0	49	0
other	Rash	Skin and subcutaneous tissue disorders	Control	2	48	2
other	Constipation	Gastrointestinal disorders	Intervention	1	49	1
other	Constipation	Gastrointestinal disorders	Control	2	48	2
other	Edema	General disorders	Intervention	0	49	0
other	Edema	General disorders	Control	2	48	2
other	Transient chest pain	Cardiac disorders	Intervention	1	49	1
other	Transient chest pain	Cardiac disorders	Control	0	48	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention	0	49
Total, all-cause mortality	Control	0	48
Total, other adverse events	Intervention	8	49
Total, other adverse events	Control	13	48
Total, serious adverse events	Intervention	6	49
Total, serious adverse events	Control	8	48

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28646887	DERIVED	PubMed
32011642	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention vs Control: Number of Participants With Serious Bleeding	Trial comparisons
Intervention vs Control: Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention	Trial comparisons
Intervention vs Control: Mortality	Trial comparisons
Intervention vs Control: deaths from any cause	Trial comparisons
Intervention vs Control: Number of Participants With Hospital Readmission	Trial comparisons
Intervention vs Control: Number of Participants With Further Interventions	Trial comparisons
Intervention vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01717742

GET https://conductscience.org/api/trials/v1/NCT01717742/results?page=2

API reference For AI assistants